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U.S. Department of Health and Human Services

Drugs

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Global Supplement Status

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00921

Version Number. 001

Data Element Name. Global Supplement Status

Description. This standard provides for all global supplement status codes. A global supplement is a group of supplements covering the identical change, and from a single sponsor.

Source. Office of Generic Drug Products

Relationship.

FDA Specifications. None.

CDER Specifications. Global Supplement Status shall consist of an alphabetic term which has a maximum length restricted to 100 characters, with the comma and hyphen being the only punctuation permissible. Codes representing each Global Supplement Status shall consist of digits.

FDA Approved Date. None.

CDER Approved Date. September 6, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

DEFINITION NAME FDA CODE
GLOBAL GRANTED Literal 1
GLOBAL TENTATIVE Literal 2
GLOBAL DENIED Literal 3